Right-sided stellate ganglion block for persistent long COVID symptoms

Effect of Stellate Ganglion Block Treatment on Long COVID Symptoms: A Single-Blind, Single-Center Randomized Controlled Trial (STAR-CO)

This trial will test whether a single right-sided stellate ganglion block with bupivacaine can help adults with long COVID who have ongoing breathlessness, fatigue, and cognitive problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (other)
• Locations: 1 site (Trois-Rivières, Quebec)
• Trial ID: NCT07374562 on ClinicalTrials.gov

What this trial studies

This single-center, randomized, controlled, single-blind trial assigns about 40 adults with long COVID in a 1:1 ratio to either an ultrasound-guided right-sided stellate ganglion block with bupivacaine or a placebo saline injection into the sternocleidomastoid muscle. Participants are followed for 26 weeks with scheduled symptom questionnaires and functional tests. Outcomes include changes in functional status, fatigue, cognitive complaints, quality of life, dyspnea, lower-limb endurance, and orthostatic tolerance, with safety monitoring at each visit. The trial compares a one-time active nerve block to a sham injection to determine whether the procedure changes persistent long-COVID symptoms versus placebo.

Who should consider this trial

Good fit: Adults 18 or older with confirmed or presumed COVID at least three months earlier who have had persistent symptoms for at least 12 weeks, a Post-COVID Functional Status score ≥2, and dyspnea ≥2 on the mMRC scale are eligible.

Not a fit: People without persistent respiratory or autonomic-related symptoms, those with symptom duration under trial thresholds, or those with alternate explanations for symptoms may not benefit from this intervention.

Why it matters

Potential benefit: If effective, a single stellate ganglion block could reduce long-COVID symptoms and improve daily function and quality of life for some patients.

How similar studies have performed: Small case series and observational reports have suggested benefit of stellate ganglion block for post-viral and autonomic symptoms, but randomized controlled data are very limited.

Eligibility criteria

Inclusion Criteria:

* Adults aged 18 years and older
* Positive COVID-19 test confirmed by RT-PCR, antibody test, or antigen test at least 3 months prior to randomization, OR presumed COVID-19 evaluated by the site investigator (no positive test required) with an acute illness occurring after October 15, 2019 and at least 3 months prior to randomization.
* Persistent symptoms ≥12 weeks after onset of acute COVID-19 AND symptoms lasting at least 2 months. The onset date is defined as the earliest of: date of first positive test, date of first symptoms
* Post-COVID Functional Status Scale score ≥2.
* Persistent dyspnea ≥2/4 on the mMRC scale at least 12 weeks post-infection.
* Persistent COVID-19-related symptoms at the time of randomization.
* If taking medications for fatigue or cognition (e.g., sildenafil, modafinil, armodafinil, guanfacine, N-acetylcysteine, stimulants for ADHD), these must have been initiated and stable for ≥4 weeks prior to randomization. Participants are asked not to stop or alter these medications during the study if possible.
* Able and willing to provide written informed consent.
* Able to read and understand French.

Exclusion Criteria:

* Prior diagnosis of myalgic encephalomyelitis (ME) or fibromyalgia
* Being on sick leave or disability at the time of the original acute COVID-19 infection.
* Pregnancy or breastfeeding.
* Myocardial infarction within the last 12 weeks.
* Use of anticoagulant therapy.
* Glaucoma.
* Emphysema requiring home oxygen.
* Cardiac conduction abnormalities.
* Known hypersensitivity to bupivacaine.
* Previous stellate ganglion block (SGB) procedure.
* Any condition that, in the judgment of the medical investigator, makes the patient not a candidate for the proposed treatment.

Where this trial is running

Trois-Rivières, Quebec

• Centre hospitalier affilié universitaire régional — Trois-Rivières, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Marie-Claude Lehoux, Master's degree

Conditions: Long COVID, Stellate Ganglion Block, Bupivacaine